Regulatory success is more than permission to market your product. Regulatory approvals specify product labeling that limits your ability to advertise and promote your product to physicians and other key constituencies. Your regulatory strategy must be carefully aligned with your reimbursement and marketing needs. Your documentation and presentations must be accurate and persuasive to meet the requirements of regulators.
BMS Goal for Regulatory Services
To provide strategies and solutions that help our clients achieve regulatory approvals that enable market success.
BMS Regulatory Services
BMS offers regulatory services covering the full range necessary for your product to be approved.
Regulatory Submissions: IDE, PMA, 510(K), IND, NDA, etc.
Technical and Medical/Statistical Reports
Organizing and Preparing for Meetings with FDA
Quality Systems and Compliance Counseling
Medical Device and Manufacturing Design Controls
Device Classification/Predicate Device Searches
Answering Deficiency Questions
The BMS Difference in Regulatory Services
BMS has the scientific expertise and depth to make our client’s documents and presentations to the FDA professional and persuasive
BMS helps our clients obtain labeling that will facilitate market acceptance
BMS keeps current on policy and regulatory changes
BMS can structure a regulatory program that is appropriate to products in the early or late stages of product development or is already on the market
BMS participation in the ASTM, an international consensus standards organization, enables us to influence the reception of new technology by regulatory authorities actively.